Active Pharmaceutical Ingredient

Carzelesin API Manufacturer & Supplier in India

Antineoplastic IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India Export Worldwide
Carzelesin API — Mediocon Inc, Aurangabad Maharashtra India
Carzelesin — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

Carzelesin is a pharmaceutical-grade Active Pharmaceutical Ingredient (API) classified as a Antineoplastic. DNA minor groove alkylating agent. Mediocon Inc supplies high-purity Carzelesin API conforming to IP / BP / EP / USP specifications from our GMP-certified manufacturing facility in Aurangabad, Maharashtra, India.

Our Carzelesin API undergoes stringent quality control testing including assay, related substances, residual solvents, heavy metals, and microbial limits before release. Each batch is accompanied by a full Certificate of Analysis and regulatory documentation.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP pharmacopoeial compliance
  • Full CoA, MSDS/SDS, and COO documentation per batch
  • GMP-certified manufacturing facility in Aurangabad, Maharashtra
  • Consistent batch-to-batch quality with HPLC verification
  • Export-ready packaging: 25 kg HDPE drums / aluminium foil bags

Why Choose Mediocon

  • ISO 9001:2015 & WHO-GMP certified manufacturing
  • Export to 40+ countries worldwide
  • Flexible MOQ: 1 kg (R&D sample) to 500+ kg commercial lots
  • Dedicated QA team for regulatory filings (US FDA, EMA, TGA)
  • Competitive pricing with short lead times from Aurangabad facility
  • Full regulatory support: DMF, CEP/EDMF on request

Product Specifications

Product NameCarzelesin
CategoryAntineoplastic
GradeIP / BP / EP / USP
AppearanceWhite to off-white crystalline powder
StorageStore below 25 °C, in a dry place, protected from light
Packing25 kg HDPE drums / aluminium foil bags / as per requirement
HS Code29419090
OriginAurangabad, Maharashtra, India

Analytical Specifications

ParameterSpecification
AssayNLT 98.0% (dried basis)
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Related SubstancesComplies with pharmacopoeia
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / aluminium foil bags

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We supply Carzelesin and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — Schedule H compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • WHO-GMP certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability — raw material to finished API
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Microbiological testing per USP <61> / <62> / BP 2.6.12

Frequently Asked Questions — Carzelesin API

What is the minimum order quantity for Carzelesin API?
Mediocon Inc supplies Carzelesin with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact us at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Carzelesin does Mediocon supply?
We supply Carzelesin conforming to IP / BP / EP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis.
What documentation is provided with Carzelesin API?
Every shipment comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Carzelesin bulk orders?
Standard lead time is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging. Temperature-controlled logistics available where required.